NCT05126914 Multicentre Real-life Follow-up Study of Rare Epileptic Syndromes in Children and Adolescents
| NCT ID | NCT05126914 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Epilepsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-12-11 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2025-12-11 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Rare epilepsies as a whole account for 20-30% of epilepsies, but knowledge about prognostic factors is currently limited. This means that it is difficult to provide adequate information to families at diagnosis and during follow-up. Prognostic factors are also important for management as they can have an impact on the patient's outcome (time to intervention, choice of one molecule over another, etc.). Finally, few treatments are currently available for these epilepsies. One of the limitations to the development of treatments is the lack of real life data as it is difficult to create reliable primary endpoints such as the rate of patients becoming seizure free naturally compared to a therapeutic intervention. The aim of this real-life study is to evaluate the response to treatment as well as to see the evolution of cognitive and psychiatric comorbidities. As explained above, there are very few randomised trials except for 3 rare epilepsies (infantile spasm syndrome, Dravet syndrome, Lennox-Gastaut syndrome). This has led to the virtual absence of management recommendations, including for the three syndromes mentioned above, where attempts at treatment algorithms have been proposed, although these have not been able to be considered as evidence-based recommendations. As a result, there is some diversity in the management of rare epilepsies from one centre to another. However, this diversity in management can be an asset in a real-life study. This will make it possible to compare different management methods, both in terms of seizure control and medium-term outcome.
Eligibility Criteria
Inclusion Criteria: * Diagnosis for rare epilepsy (based on ORPHA codes) * holders of parental authority not opposed * Be followed in one of the declared centers of the study Exclusion Criteria: * opposition from the holders of parental authority or the patient
Contact & Investigator
Blandine DOZIERES, Dr
STUDY DIRECTOR
Hopital Robert Debré - Assistance Publique Hopitaux de Paris
Frequently Asked Questions
Who can join the NCT05126914 clinical trial?
This trial is open to participants of all sexes, up to 15 Years, studying Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05126914 currently recruiting?
Yes, NCT05126914 is actively recruiting participants. Contact the research team at blandine.dozieres@aphp.fr for enrollment information.
Where is the NCT05126914 trial being conducted?
This trial is being conducted at Angers, France, Bordeaux, France, Brest, France, Lille, France and 7 additional locations.
Who is sponsoring the NCT05126914 clinical trial?
NCT05126914 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Blandine DOZIERES, Dr at Hopital Robert Debré - Assistance Publique Hopitaux de Paris. The trial plans to enroll 1,000 participants.
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